Autologous Facial Fat Grafting Study

NCT05482425 | Completed

• 1 other identifier: STUDY21110089
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to specifically examine changes in facial skin appearance after facial fat grafting with autologous fat tissue that has either been washed with sterile saline before injecting, or left unwashed. This will be testing two variations of a standard of care surgical procedure, in two cohorts of subjects. One group will receive washed fat, and one group will receive unwashed fat, to both sides of the face. There are no experimental devices, drugs, or biological agents being used in this study. All fat tissue is autologous from the subjects treated. Significance: This study will provide evidence that may directly impact clinical practice for a common procedure in plastic surgery. Regardless of whether the null hypotheses is accepted or rejected, the data will be of direct clinical use and impact practice in the operating room.

Conditions

Facial Skin Texture; Facial Skin Pigmentation

Outcome Measures

Primary Outcomes (7)

• Change in facial skin characteristics as measured by the Fitzpatrick Wrinkle Scale (FWAS) from baseline to 12 month assessment, compared between the two cohorts. Scale (FWAS) from baseline to 12 month assessment, compared between the two cohorts.

  The Fitzpatrick Wrinkle Assessment (FWAS); The FWAS quantifies the degree of wrinkling and elastosis in subjects on a scale of 0 to 9, zero being the best possible condition and 9 to be considered the worst possible condition. Change from baseline within each subject will be calculated from baseline up to 12 month using the FWAS Score, and then overall changes compared between the two cohorts.

  Baseline, 12 months

• Change in facial skin characteristics as measured by the Skin Quality Assessment (SQA) form from baseline up to 12 month assessment, compared between the two cohorts.

  Skin Quality Assessment (SQA): The SQA assesses skin quality scale in terms of four categories: tone (dyschromia), elasticity (firmness), texture (smoothness), and radiance (brightness). Each of these four categories are measured on a scale of 0 to 4, with 0 being the best possible condition and 4 being the worst possible condition Change from the baseline within each subject will be calculated using the SQA score from baseline up to 12 month, and then overall changes compared between the two cohorts.

  Baseline, 12 months

• Change in facial skin characteristics as measured by the Subject Satisfaction Scale (SSA) form from baseline up to 12 month assessment, compared between the two cohorts.

  Subject Satisfaction Scale (SSA):The SSA was designed to assess subject overall satisfaction with rejuvenation treatment and skin care products. The scale is defined as following: * 3 (very dissatisfied) * 2 (dissatisfied) * 1 (somewhat dissatisfied) 0 (neutral) 1. (somewhat satisfied) 2. (satisfied) 3. (very satisfied) Change from baseline within each subject will be calculated using the SSA score from baseline up to 12 month, and then overall changes compared between the two cohorts.

  Baseline, 12 months

• Self esteem as measured by the Heatherton and Polivy State Self Esteem Scale (SESS) form from baseline to 12 month assessment, compared between the two cohorts.

  Heatherton and Polivy State Self-Esteem Scale (SESS); The SSES is a validated instrument with multiple statements characterizing self-esteem on a scale from one to 5. (One being no self-esteem and five being extreme self-esteem.) Change from baseline within each subject will be calculated using the SESS score from baseline to 12 month, and then overall changes compared between the two cohorts.

  Baseline, 12 months

• Change in facial skin characteristics as measured by the Global Aesthetic Improvement Scale (GAIS) form from baseline to 12 month assessment, compared between the two cohorts.

  Global Aesthetic Improvement Scale (GAIS); The GAIS is a validated five-point relative improvement scale. This scale has been used in previous studies to evaluate for change in subject appearance following treatment. The scale is defined as following: 1. Exceptional improvement 2. Very improved patient 3. Improved patient 4. Unaltered patient 5. Worsened patient Change from baseline within each subject will be calculated using the GAIS score from baseline to 12 month, and then overall changes compared between the two cohorts.

  Baseline, 12 months

• Change in facial skin characteristics as measured by the Participant Satisfaction questionnaire from baseline to 12 months, compared between the two cohorts.

  Participant Satisfaction Questionnaire- participants will be asked to rate their facial appearance in specific aspects of the face such as cheek wrinkles, skin clarity, and skin smoothness, etc., using a 9 point scale (with 0 being the best possible condition and 9 being the worst possible condition. In addition, participants will rate level of their perceived level of improvement in those same facial aspects on a 9 point scale,. Change within each subject will be calculated using the participant satisfaction questionnaire score from baseline to 12 month, and then overall rates compared between the two cohorts.

  12 month

• Change in facial skin characteristics as measured by the cutometer from baseline up to 12 months, compared between groups.

  Assessment of skin elasticity by Cutometer® Dual MPA 580: The instrument applies a vacuum to a small area of skin, and measures the elastic response of the skin. The probe will be kept at a 90# angle during the measurements. This assessment will be performed on each side of the face at the intersection of lines extending down from the center of the eye and horizontally across the bottom of the nose. Reduction in wrinkle size will be assessed at baseline and 12 months, and overall rate of change compared between the two cohorts.

  Baseline, 12 months

Secondary Outcomes (3)

• Change in facial skin characteristics by expert graders using a Griffth scale.

  Baseline, 12 months

• Compare investigator's rating of the change in facial skin characteristics, as recorded during baseline and 12 month history and physical exam form, compared between the two cohorts.

  Baseline, 12 months

• To assess the safety of the autologous fat injections, compared between the two cohorts, from baseline to 12 months.

  Baseline, 12 months

Study Arms (2)

Autologous facial fat graft injection- washed fat

OTHER

Washed fat injected into both the left and right sides of the face.

Other: Autologous facial fat graft injection

Autologous facial fat graft injection-unwashed fat

OTHER

Unwashed fat injected into both the left and right sides of the face.

Other: Autologous facial fat graft injection

Interventions

Autologous facial fat graft injection OTHER

Participants will received either a washed or unwashed autologous facial fat graft injection to both sides of the face, as determined by randomization.

Autologous facial fat graft injection- washed fat; Autologous facial fat graft injection-unwashed fat

Eligibility Criteria

• Age: 35 Years - 70 Years
• Gender Eligibility Details: Healthy female adults, from 35-70 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to perform informed consent
• Healthy female adults, from 35 to 70 years of age
• Fitzpatrick Skin Type Scale scores \< 3.
• FWAS-greater than moderate, equal to or greater than 4
• Noticeable Physical signs of facial aging and sun damage including skin wrinkles, loss of elasticity and pigmentary changes, with greater than mild (≥4 on a 0 to 9 scale) signs of the following, per investigator discretion
• Facial wrinkles (periorbital//periorbital//cheek)
• Dyschromia (hyperpigmentation//uneven skin tone)
• Rough skin texture (visual skin roughness//pore sizes)
• Willingness to undergo the proposed treatment and comply with study procedures.
• Negative pregnancy urine dip test (as indicated-unless s/p hysterectomy or past menopause documentation can be sourced to research chart.)
• Willingness to avoid the use of laser, IPL, Botox (6 months), injectable fillers or other surgical cosmetic procedures on the face for 6 months ducts
• Ability to produce sufficient fat tissue from donor site during harvest (up to a maximum of 1 liter)

You may not qualify if:

• Age \< 35 or \> 70 years of age
• Any medical condition that would preclude safe administration of anesthesia and safe conduct of the adipose harvest procedure (such as an uncontrolled bleeding disorder or severe pulmonary disease), per investigator discretion.
• Active infection on the face (e.g., acne, HSV (herpes simplex), etc.,) per investigator discretion.
• Received laser, IPL, botox (6 months), injectable fillers or other surgical cosmetic procedures on the face within 12 months of study consent and screening date. -prohibited for 6 months
• Acutane use within past 12 months
• Individuals with any contraindications of autologous lipografting, such as cutaneous rashes or infection in the area of intended fat harvest, lack of available donor fat, or other factors that, in the determination of the investigator, would be considered a contraindication.
• Individuals diagnosed with known allergies to skin care products, topical antibiotics, adhesives, bandages, lidocaine, epinephrine, or other agents that might be used in the study
• Individuals with any disease state or inappropriate physical skin condition (e.g., active/history of psoriasis, active eczema, excessive hair, scars, tattoos, etc. on face) that might impair evaluations or increase the health risk to the subject by participation in the opinion of the Investigator
• Individuals with a history of immunosuppression/immune deficiency disorders/ known or suspected defect of healing (including HIV infection or AIDS)
• Individuals with an uncontrolled disease such as hypertension, hyperthyroidism, or hypothyroidism, which may impact safety. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, which in the opinion of the Investigator, may create safety concerns or interfere with the study.
• Individuals currently taking substances known to affect bleeding time, which in the opinion of the Investigator, may create safety concerns or interfere with the study (e.g., aspirin, Heparin, Warfarin, Plavix, supplements, etc.).
• Individuals currently and chronically taking substances known to impair the immune system at doses anticipate to have a systemic effect on wound healing (e.g., corticosteroids, immunosuppressant, etc. or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) within 30 days of the study start and in the discretion of the PI would impact the results of the study. Steroid treatments that would not be expected to impact study results could include steroid inhaler, nasal spray, eyedrops, topical creams used in areas outside of the face, or transient oral dose of steroids to treat acute conditions (eg pulsed oral dose for respiratory airway constriction or skin rash)
• Individuals with a history of documented keloid scar formation, prominent skin lesions or scars that would render data collection and aesthetic evaluation impossible. The investigator will make that determination based on examining other scars and reviewing any history of treatment for keloid lesions.
• Individuals with a diagnosis of diabetes
• Subject participating in another interventional clinical trial assessing treatments that may interfere with the accuracy of data collection for this study within 1 month of Visit 1

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Aesthetic Plastic Surgery Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (13)

• Strong AL, Cederna PS, Rubin JP, Coleman SR, Levi B. The Current State of Fat Grafting: A Review of Harvesting, Processing, and Injection Techniques. Plast Reconstr Surg. 2015 Oct;136(4):897-912. doi: 10.1097/PRS.0000000000001590.

  PMID: 26086386 BACKGROUND

• Plastic Surgery Statistics. Plastic surgery procedural statistics from the American Society of Plastic Surgeons. Accessed January 21, 2022. https://www.plasticsurgery.org/news/plastic-surgery-statistics

  BACKGROUND

• Wollina U, Wetzker R, Abdel-Naser MB, Kruglikov IL. Role of adipose tissue in facial aging. Clin Interv Aging. 2017 Dec 6;12:2069-2076. doi: 10.2147/CIA.S151599. eCollection 2017.

  PMID: 29255352 BACKGROUND

• Egro FM, Coleman SR. Facial Fat Grafting: The Past, Present, and Future. Clin Plast Surg. 2020 Jan;47(1):1-6. doi: 10.1016/j.cps.2019.08.004. Epub 2019 Oct 21.

  PMID: 31739886 BACKGROUND

• Schultz KP, Raghuram A, Davis MJ, Abu-Ghname A, Chamata E, Rohrich RJ. Fat Grafting for Facial Rejuvenation. Semin Plast Surg. 2020 Feb;34(1):30-37. doi: 10.1055/s-0039-3402767. Epub 2020 Feb 15.

  PMID: 32071577 BACKGROUND

• Marten T, Elyassnia D. Facial Fat Grafting: Why, Where, How, and How Much. Aesthetic Plast Surg. 2018 Oct;42(5):1278-1297. doi: 10.1007/s00266-018-1179-x. Epub 2018 Aug 31.

  PMID: 30171292 BACKGROUND

• Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7.

  PMID: 16936550 BACKGROUND

• Evans BGA, Gronet EM, Saint-Cyr MH. How Fat Grafting Works. Plast Reconstr Surg Glob Open. 2020 Jul 14;8(7):e2705. doi: 10.1097/GOX.0000000000002705. eCollection 2020 Jul.

  PMID: 32802628 BACKGROUND

• Mojallal A, Lequeux C, Shipkov C, Breton P, Foyatier JL, Braye F, Damour O. Improvement of skin quality after fat grafting: clinical observation and an animal study. Plast Reconstr Surg. 2009 Sep;124(3):765-774. doi: 10.1097/PRS.0b013e3181b17b8f.

  PMID: 19730294 BACKGROUND

• Khouri RK Jr, Khouri RE, Lujan-Hernandez JR, Khouri KR, Lancerotto L, Orgill DP. Diffusion and perfusion: the keys to fat grafting. Plast Reconstr Surg Glob Open. 2014 Oct 7;2(9):e220. doi: 10.1097/GOX.0000000000000183. eCollection 2014 Sep.

  PMID: 25426403 BACKGROUND

• Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.

  PMID: 23783059 BACKGROUND

• Xue EY, Narvaez L, Chu CK, Hanson SE. Fat Processing Techniques. Semin Plast Surg. 2020 Feb;34(1):11-16. doi: 10.1055/s-0039-3402052. Epub 2020 Feb 15.

  PMID: 32071574 BACKGROUND

• Kling RE, Mehrara BJ, Pusic AL, Young VL, Hume KM, Crotty CA, Rubin JP. Trends in autologous fat grafting to the breast: a national survey of the american society of plastic surgeons. Plast Reconstr Surg. 2013 Jul;132(1):35-46. doi: 10.1097/PRS.0b013e318290fad1.

  PMID: 23806907 BACKGROUND

Study Officials

• J. Peter Rubin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Patsy Simon, BS, RN, CCRC, CCRA, ACRP-PM

  University of Pittsburgh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded grading based on VECTRA images and VISIA images will be performed on de-identified photography by a third-party vendor at the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UPMC Endowed Professor and Chair of Plastic Surgery

Model Details: This study will include 2 cohorts, each consisting of approximately 13 subjects to undergo intervention, where each subject will have treatment of the skin of cheek area, upper lip, chin and superior neck regions, as well as the behind the ears with autologous fat graft. The subject will receive either a saline washed preparation or a non-washed preparation as determined by the randomization process. Autologous fat tissue will be harvested for the fat graft preparation (up to a maximum of 1 liter ) from the trunk or extremity donor site, consistent with standard clinical practice.

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: August 1, 2022
• Study Start: October 17, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)